Medical Device Recalls
This is our largest category by volume. The FDA tracks recalls for an enormous range of medical devices: implants, pacemakers, insulin pumps, surgical tools, blood glucose monitors, X-ray machines, prosthetics, contact lenses, and home health equipment, among many others. We have records dating back to 2005 and add new ones as the FDA publishes them.
Device recalls can happen because of software bugs, manufacturing defects, bacterial contamination, incorrect labeling, or design flaws that lead to inaccurate results or equipment failure. Class I recalls are the most serious and mean the device could cause injury or death.
Showing 16161–16180 of 38,428 recalls
Recalled Item: Microbiologics QC Sets and Panels
The Issue: The recommended hydration fluid for the 8180 Gram-Positive
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Beckman Coulter MicroScan PROMPT Inoculation System-D
The Issue: Due to customer reports it has been determined
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: HUDSON RCI COMFORT FLO Humidification System
The Issue: There is the potential for water to flood
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: HUDSON RCI COMFORT FLO Corrugated Humidification System
The Issue: There is the potential for water to flood
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: HUDSON RCI COMFORT FLO Humidification System With Remote Temperature Port
The Issue: There is the potential for water to flood
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: HUDSON RCI COMFORT FLO Corrugated Humidification System with Remote Temperature
The Issue: There is the potential for water to flood
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Liquid Clinical Chemistry Control
The Issue: A transcription error has occurred for the Randox
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ADVANCED ENDOSEE System CANNULA
The Issue: for unsealed pouches in two (2) lots
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Coonrad/Morrey Total Elbow Humeral Assembly
The Issue: The lot contained two outer pins instead of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ResMed Stellar
The Issue: Combination of software and a component failure may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Arrow Arterial Catherization Kit-20 Ga. x 4.45 cm Radiopaque Polyurethane
The Issue: The lidstock label incorrectly displays a MR (Magnetic
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Clearlink System Continu-Flo Administration Sets
The Issue: Continu-Flo sets with male Luer bodies at the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ONE-LINK Needle-free IV Connector
The Issue: Continu-Flo sets with male Luer bodies at the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Piccolo Xpress chemistry analyzer
The Issue: Incorrect reference ranges of analytes
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Accu-Chek Aviva Plus Health Network Strips- intended for Blood Glucose
The Issue: Inability to dose the test strips, may result
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Centurion- Umbilical Trays UVT1045 UMBILICAL ARTERY TRAY UVT1055 UVC KIT
The Issue: Incomplete seals on the sterile package may compromise
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Centurion- ENT SNUF3 SNUFFER KIT Y
The Issue: Incomplete seals on the sterile package may compromise
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Centurion- HT5555A HYPERALIMENTATION & DRSG CHG TRAY
The Issue: Incomplete seals on the sterile package may compromise
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Centurion- Skin Prep Kits SB1280 SKIN SCRUB KIT SB1525 VAGINAL PREP TRAY
The Issue: Incomplete seals on the sterile package may compromise
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Centurion- Dressing Change Tray DT10290S CENTRAL LINE PREPARATION PACK DT10290S
The Issue: Incomplete seals on the sterile package may compromise
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.